Canagliflozin Tablet, Film Coated
NDC Package 17314-577-00

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Canagliflozin tablets is canagliflozin is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. This formulation utilizes a tablet, film coated delivery system. Marketed by Janssen Ortho Llc, this product is identified by NDC 17314-577.

Identification & Billing

NDC Package Code
17314-577-00
Package Description
21088 TABLET, FILM COATED in 1 DRUM
Product Code
17314-577
11-Digit Billing Format
17314057700

Clinical Specifications

Proprietary Name
Canagliflozin
Non-Proprietary Name
Canagliflozin
Substance Name
Canagliflozin
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Active Ingredient(s)
CANAGLIFLOZIN 300 mg/1
Usage Information
Canagliflozin is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Canagliflozin is also used by people with type 2 diabetes and heart disease to lower the risk of death from heart attack or stroke. Canagliflozin is also used by people with type 2 diabetes and kidney disease to lower the risk of dialysis, death from heart disease, and the need to go to the hospital for heart failure. Canagliflozin works by increasing the removal of sugar by your kidneys.

Regulatory & Marketing

Labeler Name
Janssen Ortho Llc
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
09-20-2016
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 17314-577-00 identifies a specific commercial package of 21088 tablet, film coated in 1 drum of Canagliflozin (UNFINISHED drug), drug for further processing labeled by Janssen Ortho Llc. This tablet, film coated is formulated for use and contains canagliflozin as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Janssen Ortho Llc on September 20, 2016. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Canagliflozin is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Canagliflozin is also used by people with type 2 diabetes and heart disease to lower the risk of death from heart attack or stroke. Canagliflozin is also used by people with type 2 diabetes and kidney disease to lower the risk of dialysis, death from heart disease, and the need to go to the hospital for heart failure. Canagliflozin works by increasing the removal of sugar by your kidneys.

How is this Janssen Ortho Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17314057700. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
17314-577-00
11-Digit CMS (5-4-2)
17314-0577-00

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.